MDCG Guideline on Safety Reporting in Performance Studies of In Vitro Diagnostic Medical Devices in accordance with Regulation (EU) 2017/746

The safety reporting guideline in performance studies of in vitro medical devices (IVD) under Regulation (EU) 2017/746, published by the Medical Device Coordination Group (MDCG) of April 2024, provides comprehensive instructions with the aim of ensuring consistent and effective monitoring of the safety of study participants and the quality of IVD products in the European Union. This extends the MDCG guidelines (2020-10/1 Rev 1, “Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745” from October 2022 to include in vitro diagnostics.

The MDCG Guideline sets detailed procedures and requirements for safety reporting in IVD performance studies, including the definition of reportable events, reporting deadlines, causality assessment and use of standardised reporting forms to ensure harmonised and effective security monitoring in the EU until the EUDAmed system is fully implemented.

Scope and objective

The scope covers various types of studies under Articles 58 (1), 58 (2), 70 (1) and 70 (2) of the IVD Regulation, including post-market performance follow-up (PMPF) studies. The aim is to ensure the safety of study participants and the quality of study results through uniform and effective safety reporting, in conjunction with other relevant EU regulations and guidelines.

An important aspect is the mention of combined studies of drugs and IVDs, which reflects the increasing complexity of modern clinical research. The guide should take into account various study designs and objectives while ensuring consistent reporting.

Reporting method

The standardized reporting form, which serves as a temporary solution until the EUDAMED system is fully operational, is described in the annex to the guide. The method includes instructions on how to collect and submit relevant security information. Particular attention is paid to ensuring consistent and complete reporting across all Member States. The chapter also discusses the planned transition to electronic reporting via EUDAMED. Practical advice is provided on how sponsors and auditors can make reporting efficient to ensure timely and accurate transmission of safety-relevant information.

Reportable events

Categorizations of incidents (see Article 76 (2) of the IVD Regulation) that require immediate notification are listed, such as serious adverse events and product deficiencies that could lead to such events. A distinction is made between different types of studies, with specific regulations for PMPF studies being emphasized. Guidelines are provided to assess the reportable nature of events to avoid excessive reporting while ensuring that all relevant safety information is collected. The clear definition of reportable events is crucial for effective security monitoring and helps to harmonise reporting in the EU.

Reporting and deadlines

Sponsors of the performance study or their delegates must report the reportable events to all national authorities and, where applicable, to ethics committees. The deadlines for various types of reports are specified, distinguishing between immediate reporting (up to a maximum of 2 calendar days) for serious events and longer time limits (but not later than 7 calendar days) for less critical incidents. It is the sponsor's responsibility to ensure that investigators report reportable events immediately, but not later than 3 days after they become known. Exceptions can be agreed with national authorities in individual cases.

Causality assessment

Four categories of causality are defined, from “securely related” to “not contiguous,” based on the test product, comparator or study procedure. The evaluation is based on factors such as temporal context, biological plausibility and the exclusion of alternative causes and, as a complex process, requires clinical judgment and a thorough analysis of all available information. In case of doubt, higher assessments of causality are necessary. Further evaluations may be necessary in the course of the performance study and unclear classifications must be avoided with maximum effort on the part of those responsible.

Report form

The report form attached to the document serves as a central tool for safety reporting. The detailed instructions for completing each section of the form must be implemented by qualified personnel to ensure a complete and accurate collection of all relevant information, including the correct coding of events and the provision of sufficient details. This includes study and product identification, description of the event, causality assessment and measures taken for effective safety monitoring.

Precise knowledge of reporting requirements, deadlines and procedures helps you as a manufacturer not only to ensure regulatory compliance, but also to identify and address potential safety risks at an early stage and to increase trust in innovations.

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Source and detailed information: https://health. ec.europa.eu/document/download/5cc894e0-331d-4fa2-8ab3- cdd4437c48fc_en?filename=mdcg_2024 -4_en.pdf (delete spaces for the link)

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